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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease Control (CDC)-identified best-evidence HIV behavioral intervention designed to reduce substance abuse, family violence, and HIV/AIDS (SAVA) among sexually active heterosexual Latino seasonal farmworkers (LSFWs) in rural areas.
The HoMBRES de Familia project study (HoMBRES) examined the efficacy of a culturally adapted group intervention program with fathers from a seasonal farm working community and an Urban community in South Florida. The HoMBRES intervention study adapted and tested the efficacy of an intervention that can be adopted, implemented, and sustained with Latino fathers who live or work in the farm industry, construction, services, self employed or any other work industry in the semi-rural areas and urban areas of Miami Dade County. The HoMBRES intervention seeked to reduce risk for the SAVA (Substance Abuse, Violence, and HIV/AIDS infection) syndemic among this group of men and their adolescent sons.
The intervention HoMBRES consisted of four sessions remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session). Staff scheduled the times when participants will watch the videotaped sessions in order to be available for their questions. Intervention videos were followed up with a telephone call to discuss presentation and respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone. Video sessions were completed within two weeks time period. Participants in the control group received one single video on diabetes prevention. Both groups were followed up six months post baseline interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HoMBRES Intervention Group - Father | Experimental | Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions; During the period of social distancing, interventions were remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session. Intervention videos were followed up with a telephone call to respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone or videoconferences. Only fathers were included in this group. |
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| Diabetes Prevention Intervention Group - Father | Active Comparator | One session of 1.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight. Only fathers were included in this group. |
|
| HoMBRES Intervention Group - Adolescent | No Intervention | The adolescent received no intervention. | |
| Diabetes Prevention Intervention Group - Adolescent | No Intervention | The adolescent received no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HoMBReS intervention | Behavioral | Adapted intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors, substance abuse and HIV among recently immigrated rural and urban men. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | The number of participants that responded 'yes' to any of the following questions on the PhenX Toolkit Sexual Risk Behavior will be reported as self-reporting engagement in risky sexual behaviors; a) engaging in unprotected sexual encounters, b) more than one partner, c) anal sex with man in the last 6 months. | At Baseline, at 6 months follow up |
| The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | As measured using the PhenX Toolkit Exposures to Violence self-reported instrument. The variable was recoded using four categories: (1) "Your partner physically hurt you; (2) Insult or talk down to you; (3) Threaten you with harm; (4) Scream or curse at you. The responses are scored on a Likert-type scale 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, and 5=Always. The number of participants reporting 3 or higher on the Likert scale to any of the four categories, will be recorded as experiencing intra-partner violence. | At Baseline, at 6 months |
| The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire. | At Baseline, at 6 months |
| HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | As measured by the Brief HIV Knowledge Questionnaire. The proportion of correct answers will be reported (ranging from 0 to 1), with a score closer to 1 indicating higher HIV knowledge. | At Baseline, at 6 months |
| HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | Self-Efficacy for Sexually Transmitted Infection (STI) and HIV Scale is a 9-item scale measuring the level of confidence in the ability to prevent STI and HIV infection. The measure uses a 5-point Likert scale (1=not sure at all to 5= completely sure). Total score ranges 9 to 45, with a higher score indicating a higher level of HIV self-efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | The self-reported Parenting Practices Scale has a total score ranging from 1-5, with higher scores indicating higher levels of parental monitoring among the fathers. The adolescents responded to the son's version of the scale. | At Baseline, At 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Gender identity is self-reported.
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Behar-Zusman, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University | Miami | Florida | 33199 | United States |
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Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | HoMBRES Intervention Group - Father | Participants in the intervention study will receive the adapted HoMBRES intervention which consisted of four participatory lectures and discussion session with the facilitator. Only fathers participated in the intervention group. |
| FG001 | Diabetes Prevention Intervention Group - Father |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2020 |
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| Families Talking Together (FTT) | Behavioral | The brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, reduce alcohol use, risky sexual behaviors and prepare them to teach adolescents assertiveness and substance abuse refusal skills. |
|
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| Diabetes Prevention Intervention | Behavioral | Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight. |
|
| At Baseline, at 6 months |
| The Number of Drinks Per Day Over the Past 90 Days. | The number of drinks per day over the past 90 days using the Timeline Followback. | At Baseline, at 6 months |
Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only Fathers participated in the Diabetes Prevention Intervention Group. |
| FG002 | HoMBRES Intervention Group - Adolescent | The adolescents with the fathers from the HIV/AIDS intervention did not receive any of the adult intervention sessions. |
| FG003 | Diabetes Prevention Intervention Group - Adolescent | The adolescent from the diabetes prevention intervention with the fathers did not receive the adult intervention. |
| COMPLETED |
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| NOT COMPLETED |
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Only the father received the study intervention and completed the questionnaires that were included in the data for the primary outcomes. Youth were only included in the secondary outcomes. The adolescent received no intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | HoMBRES Intervention Group - Father | Participants in the intervention study will receive the adapted HoMBRES intervention which consisted of three participatory lectures and discussion session with the facilitator. Only fathers are included in this group. |
| BG001 | Diabetes Prevention Intervention Group - Father | Participants in the Diabetes group received a single participatory lecture on diabetes prevention and discussion session with the facilitator. Only fathers are included in this group. |
| BG002 | HoMBRES Intervention Group - Adolescent | Adolescent from the did not receive any intervention. They only participated in baseline and six months follow up. |
| BG003 | Diabetes Prevention Intervention Group - Adolescent | Adolescent did not receive any intervention. They only participated in baseline and six months follow up. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Demographics data was collected from both Fathers and sons. Adolescents did not participate in the interventions sessions. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participant Fathers Self-reporting Engagement in Risky Sexual Behaviors | The number of participants that responded 'yes' to any of the following questions on the PhenX Toolkit Sexual Risk Behavior will be reported as self-reporting engagement in risky sexual behaviors; a) engaging in unprotected sexual encounters, b) more than one partner, c) anal sex with man in the last 6 months. | Not all participants completed the questions required. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset. | Posted | Count of Participants | Participants | At Baseline, at 6 months follow up |
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| Primary | The Number of Participant Fathers Self-reporting Experiences of Intra-partner Violence | As measured using the PhenX Toolkit Exposures to Violence self-reported instrument. The variable was recoded using four categories: (1) "Your partner physically hurt you; (2) Insult or talk down to you; (3) Threaten you with harm; (4) Scream or curse at you. The responses are scored on a Likert-type scale 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, and 5=Always. The number of participants reporting 3 or higher on the Likert scale to any of the four categories, will be recorded as experiencing intra-partner violence. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset. | Posted | Count of Participants | Participants | At Baseline, at 6 months |
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| Primary | The Number of Days Participant Fathers Reported Drinking in the Past 90 Days. | The number of days participant reported drinking in the past 90 days using the Time-Line Followback self-reported questionnaire. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset. | Posted | Mean | Standard Deviation | days | At Baseline, at 6 months |
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| Primary | HIV Knowledge as Measured by the Brief HIV Knowledge Questionnaire | As measured by the Brief HIV Knowledge Questionnaire. The proportion of correct answers will be reported (ranging from 0 to 1), with a score closer to 1 indicating higher HIV knowledge. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary outcomes and adolescents were only included in the secondary outcomes. The adolescent received no intervention and were not included in the primary outcome dataset. | Posted | Mean | Standard Deviation | units on a scale | At Baseline, at 6 months |
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| Primary | HIV Self-Efficacy as Measured by Self-Efficacy for STI and HIV Scale | Self-Efficacy for Sexually Transmitted Infection (STI) and HIV Scale is a 9-item scale measuring the level of confidence in the ability to prevent STI and HIV infection. The measure uses a 5-point Likert scale (1=not sure at all to 5= completely sure). Total score ranges 9 to 45, with a higher score indicating a higher level of HIV self-efficacy. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, at 6 months |
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| Primary | The Number of Drinks Per Day Over the Past 90 Days. | The number of drinks per day over the past 90 days using the Timeline Followback. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent received no intervention and were not included in the dataset. | Posted | Mean | Standard Deviation | drinks per day | At Baseline, at 6 months |
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| Secondary | Level of Self-reported Communication With Son as Measured by the Parental Practicing Scale | The self-reported Parenting Practices Scale has a total score ranging from 1-5, with higher scores indicating higher levels of parental monitoring among the fathers. The adolescents responded to the son's version of the scale. | Two participants did not complete the 6-months follow up interview in the HoMBRES group. Only the father received the study intervention and completed the questionnaires that were included in the data for the primary and secondary outcomes. The adolescent did not receive any interventions and were not included in the dataset. | Posted | Mean | Standard Deviation | score on a scale | At Baseline, At 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HoMBRES Intervention Group - Father | Four sessions (2 sessions per week, approximately 1.5 hours each) with the fathers, in which facilitators conduct educational sessions with groups of 6-8 men per group. One of the sessions includes an intervention of families talking together. Only fathers were included in this group. HoMBReS intervention: The experimental group (group A) will receive an intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors among recently migrated rural men. Families Talking Together (FTT): The brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, and prepare them to teach adolescents assertiveness and substance abuse refusal skills. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG001 | Diabetes Prevention Intervention Group - Father | One session of 1.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight. Only fathers were included in this group. Diabetes Prevention Intervention: Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG002 | HoMBRES Intervention Group - Adolescent | Adolescent did not received intervention. They only participated in the baseline and six month follow up interviews. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG003 | Diabetes Prevention Intervention Group - Adolescent | Adolescent did not received intervention. They only participated in the baseline and six month follow up interviews. | 0 | 61 | 0 | 61 | 0 | 61 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victoria Behar-Zusman | University of Miami | 305-2849139 | vbehar-zusman@miami.edu |
| Aug 1, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2020 | Oct 15, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6 months follow up |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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Adolescents from the Fathers' intervention group did not participate in the intervention sessions. They only participated in the baseline and follow up interviews. |
| OG003 | HoMBRES Diabetes Control Group - Adolescent | Adolescents from the Fathers' control group did not participate in the control group sessions. They only participated in the baseline and follow up interviews. |
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| Title | Measurements |
|---|---|
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